Biosect, I was previously told that there are multiple quality levels that may be used in trials. Phase 1/2's are generally lower quality only intended to demonstrate some efficacy and safety and hopefully are sufficient to continue into full Phase 2 or 3 trials.
Phase 2 can be done with pivotal quality material, if you want the data to be considered for approval, but can be done with lesser grade.
Phase 3 must be done with pivotal quality material, essentially it's commercial quality, but can be made in equipment smaller than will be used for commercial production.
Companies may invest in building commercial capability early and utilize it at any time, but they can also wait until they feel confident of approval in time, as long as they have commercial capability ready for inspection when needed in the approval process.
Many companies, even the biggest BP's often choose to have CDMO's produce their products and not invest in commercial equipment themselves. It's a pay me now, pay me later situation, you make a little less if someone else does the production, but of course you also invest less. I don't believe that NWBO ever intended to own the entire production facility making the vaccine, even if LP does own a major interest in one of the CDMO's producing it.
Gary
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